Federal health agencies are lifting a pause on Johnson & Johnson’s Covid-19 vaccine, after the US Centers for Disease Control and Prevention uncovered 15 cases of a rare blood clot, three of which were fatal.
More than 8 million people in the US have received the Johnson & Johnson vaccine.
In its second meeting within 10 days, the CDC’s Advisory Committee on Immunization Practices argued that the benefits to the single-dose vaccine outweigh potential risks, and suggested that the vaccine come with a warning to those potentially receiving it.
The FDA and CDC allowed for the immediate administration of the vaccine following the panel’s guidance.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” CDC Director Rochelle Walensky said on Friday.
FDA Commissioner Dr Janet Woodcock said the agency concluded that “the known and potential benefits of the ... vaccine outweigh its known and potential risks in individuals 18 years of age and older.”
“We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality,” she said. “We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”
Roughly 10 million Johnson & Johnson vaccines are awaiting distribution in the US, as state and local governments had looked to the single-dose vaccine to ramp up innoculation efforts.
The pause “was essential to our ability to inform the public” of the rare condition linked to the vaccine, said Dr Jose R Romero, advisory panel chair.
Last week, officials recommended against the administration of the vaccine “out of an abundance of caution” after six women who received the shot – among more than 8 million people who the CDC has recorded receiving that vaccine – were diagnosed with a rare blood clot condition.
Nine additional women were reported with the condition on Friday. Three women died, seven were hospitalised and five are recovering, according to the board.
The CDC panel also issued additional guidance to doctors and health officials for patients who are diagnosed with clots within three weeks of receiving the vaccine.
Roughly 52 per cent of adults across the US have had at least one shot of the three available US vaccines, including Johnson & Johnson’s and the two-dose Pfizer and Moderna vaccines, according to the CDC.
The seven-day average for the number of daily shots is roughly 2.9 million per day.